510(k) · Cleared
ClearedReveneer Ceramic Repair System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schutz-Dental GmbH · KLE Agent, Tooth Bonding, Resin
Cleared on Oct 17, 2005 as substantially equivalent to K974089 (Kuraray America, Inc., 1997) and 3 other predicates after a 67-day review. Its family tree reaches back 2 generations to 1987.
- Decided
- Oct 17, 2005
- Review
- 67 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K871636 (1987). 7 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K871636 | Clearfil Porcelain Bond | Kuraray Co. | 1987 | — |
| −1 | K974089 | Alloy Primer | Kuraray America, Inc. | 1997 | — |
| 0 (this device) | K052189 | Reveneer Ceramic Repair System | Schutz-Dental GmbH | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1997 | 2 | 0 |
| 2004 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KLE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KLE device
- #1 K262252 MPa Max adhesivescore 15.1 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K974089 | Alloy PrimerSummary page 1…. (872.3690) Legally marketed equivalent devices: 1. Kuraray Alloy Primer (510(k) no.: K974089) 2. Kuraray Clearfil Photo Bond… | 1997 |
| * | K943165 | Clearfil Photo BondSummary page 1…(510(k) no.: K974089) 2. Kuraray Clearfil Photo Bond (510(k) no.: K943165) 3. Shofu Vintage Halo (51… | 1994 |
| * | K973247 | Vintage HaloSummary page 1…(510(k) no.: K943165) 3. Shofu Vintage Halo (510(k) no.: K973247) 4. Ultradent Amelogen Plus… | 1997 |
| * | K043119 | Amelogen PlusSummary page 1…(510(k) no.: K973247) 4. Ultradent Amelogen Plus (510(k) no.: K043119) Public Health Service DEPARTMENT OF… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 10.5 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K974089.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KLE
149in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KLE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLE
3in 2025
MAUDE reports naming product code KLE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 71 | 2 | 18 |
| 2008 | 3 | 66 | 0 | 9 |
| 2009 | 7 | 79 | 1 | 11 |
| 2010 | 8 | 93 | 1 | 13 |
| 2011 | 10 | 100 | 0 | 69 |
| 2012 | 5 | 66 | 0 | 176 |
| 2013 | 11 | 115 | 0 | 248 |
| 2014 | 6 | 120 | 0 | 260 |
| 2015 | 10 | 118 | 0 | 100 |
| 2016 | 3 | 148 | 1 | 47 |
| 2017 | 4 | 171 | 1 | 42 |
| 2018 | 8 | 124 | 0 | 31 |
| 2019 | 6 | 143 | 0 | 20 |
| 2020 | 6 | 195 | 0 | 6 |
| 2021 | 4 | 163 | 0 | 6 |
| 2022 | 8 | 98 | 0 | 7 |
| 2023 | 6 | 75 | 0 | 7 |
| 2024 | 7 | 61 | 1 | 12 |
| 2025 | 3 | 149 | 0 | 3 |
| 2026 | 7 | 84 | 0 | — |
What is it indicated for?
ReVeneer is an intraoral and extraoral repair system for ceramic crown and bridge veneers with the following advantages:
- no acid etching (neither hydrofluoric nor phosphoric acid)
- safe intraoral use
- extremely good bond strength
- time saving
- can be used universally, with all conventional ceramics
- use of conventional curing lights (halogen, LED, plasma)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052189 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052189: Reveneer Ceramic Repair System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052189
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026